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Food Defense Plan (proposed regulation)

Congress requires that a Food Safety Plan address the risk of an intentional attack on a food business. FDA proposed a regulation in December 2013 detailing what should be considered in developing a Food Defense component for a Food Safety Plan.

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Congress updated its direction to the FDA to develop and implement regulations overseeing the safety of food, except seafood, juice, meat, poultry and eggs.  This statute -- the FDA Food Safety Modernization Act (FSMA) -- was signed by the president in early January 2011 and requires that the remaining food processing business develop and implement a HACCP-based Food Safety Plan.  The underlying statutory authority is found at 21 U.S.C. 350g; one of the proposed regulation is copied below.

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Proposed Regulation:  21 CFR PART 121 -- Focused Mitigation Strategies to Protect Food Against Intentional Adulteration

December 2013

 

§ 121.3 Definitions.

The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act are applicable to such terms when used in this part. The following definitions also apply:

Actionable process step means a point, step, or procedure in a food process at which food defense measures can be applied and are essential to prevent or eliminate a significant vulnerability or reduce such vulnerability to an acceptable level.

Contaminant means any biological, chemical, physical or radiological agent that may be intentionally added to food and that may cause illness, injury or death.

Facility means a domestic facility or a foreign facility that is required to register under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d), in accordance with the requirements of 21 CFR part 1, subpart H.

Farm means farm as defined in § 1.227 of this chapter.

FDA means the Food and Drug Administration.

Focused mitigation strategies mean those risk-based, reasonably appropriate measures that a person knowledgeable about food defense would employ to significantly minimize or prevent significant vulnerabilities identified at actionable process steps, and that are consistent with the current scientific understanding of food defense at the time of the analysis.

Food means food as defined in section 201(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(f)) and includes raw materials and ingredients.

Food defense means the effort to protect food from intentional acts of adulteration where there is an intent to cause public health harm and economic disruption.

Holding means storage of food. Holding facilities include warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks. For farms and farm mixed-type facilities, holding also includes activities traditionally performed by farms for the safe or effective storage of raw agricultural commodities grown or raised on the same farm or another farm under the same ownership, but does not include activities that transform a raw agricultural commodity, as defined in section 201(r) of the Federal Food, Drug, and Cosmetic Act, into a processed food as defined in section 201(gg).

Manufacturing/processing means making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients. Examples of manufacturing/processing activities are cutting, peeling, trimming, washing, waxing, eviscerating, rendering, cooking, baking, freezing, cooling, pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, extracting juice, distilling, labeling, or packaging. For farms and farm mixed-type facilities, manufacturing/processing does not include activities that are part of harvesting, packing, or holding.

Mixed-type facility means an establishment that engages in both activities that are exempt from registration under section 415 of the Federal Food, Drug, and Cosmetic Act and activities that require the establishment to be registered. An example of such a facility is a “farm mixed-type facility,” which is an establishment that grows and harvests crops or raises animals and may conduct other activities within the farm definition, but also conducts activities that require the establishment to be registered.

Monitor means to conduct a planned sequence of observations or measurements to assess whether focused mitigation strategies are consistently applied and to produce an accurate record for use in verification.

Packing means placing food into a container other than packaging the food. For farms and farm mixed-type facilities, packing also includes activities traditionally performed by farms to prepare raw agricultural commodities grown or raised on the same farm or another farm under the same ownership for storage and transport, but does not include activities that transform a raw agricultural commodity, as defined in section 201(r) of the Federal Food, Drug, and Cosmetic Act, into a processed food as defined in section 201(gg).

Qualified end-user, with respect to a food, means the consumer of the food (where the term consumer does not include a business); or a restaurant or retail food establishment (as those terms are defined in § 1.227 of this chapter) that:

(1) Is located:

(i) In the same State as the qualified facility that sold the food to such restaurant or establishment; or

(ii) Not more than 275 miles from such facility; and

(2) Is purchasing the food for sale directly to consumers at such restaurant or retail food establishment.

Qualified facility means (when including the sales by any subsidiary; affiliate; or subsidiaries or affiliates, collectively, of any entity of which the facility is a subsidiary or affiliate) a facility that is:

(1) A very small business as defined in this part; or

(2) A facility to which both of the following apply:

(i) During the 3-year period preceding the applicable calendar year, the average annual monetary value of the food manufactured, processed, packed or held at such facility that is sold directly to qualified end-users (as defined in this part) during such period exceeded the average annual monetary value of the food sold by such facility to all other purchasers; and

(ii) The average annual monetary value of all food sold during the 3-year period preceding the applicable calendar year was less than $500,000, adjusted for inflation.

Significant vulnerability means a vulnerability for which a prudent person knowledgeable about food defense would employ food defense measures because of the potential for serious adverse health consequences or death and the degree of accessibility to that point in the food process.

Significantly minimize means to reduce to an acceptable level, including to eliminate.

Small business means a business employing fewer than 500 persons.

Verification means those activities, other than monitoring, that establish that the system is operating according to the food defense plan.

Very small business means a business that has less than $10,000,000 in total annual sales of food, adjusted for inflation.

Vulnerability means the susceptibility of a point, step, or procedure in a facility's food process to intentional adulteration.

 

§ 121.5 Exemptions.

(a) This part does not apply to a qualified facility, except that qualified facilities must, upon request, provide for official review documentation that was relied upon to demonstrate that the facility meets this exemption. Such documentation must be retained for 2 years.

(b) This part does not apply to the holding of food, except the holding of food in liquid storage tanks.

(c) This part does not apply to the packing, re-packing, labeling, or re-labeling of food where the container that directly contacts the food remains intact.

(d) This part does not apply to activities of a facility that are subject to section 419 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350h) (Standards for Produce Safety).

(e)(1) This part does not apply with respect to alcoholic beverages at a facility that meets the following two conditions:

(i) Under the Federal Alcohol Administration Act (27 U.S.C. 201 et seq.) or chapter 51 of subtitle E of the Internal Revenue Code of 1986 (26 U.S.C. 5001 et seq.) the facility is required to obtain a permit from, register with, or obtain approval of a notice or application from the Secretary of the Treasury as a condition of doing business in the United States, or is a foreign facility of a type that would require such a permit, registration, or approval if it were a domestic facility; and

(ii) Under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d) the facility is required to register as a facility because it is engaged in manufacturing, processing, packing, or holding one or more alcoholic beverages.

(2) This part does not apply with respect to food other than alcoholic beverages at a facility described in paragraph (e)(1) of this section, provided such food:

(i) Is in prepackaged form that prevents any direct human contact with such food; and

(ii) Constitutes not more than 5 percent of the overall sales of the facility, as determined by the Secretary of the Treasury.

(f) This part does not apply to the manufacturing, processing, packing, or holding of food for animals other than man.

 

§ 121.126 Requirement for a food defense plan.

(a) Food defense plan. The owner, operator, or agent in charge of a facility must prepare, or have prepared, and implement a written food defense plan.

(b) Contents of a food defense plan. The food defense plan must include:

(1) The written identification of actionable process steps as required by § 121.130;

(2) The written focused mitigation strategies as required by § 121.135(b);

(3) The written procedures for monitoring as required by § 121.140(a);

(4) The written corrective action procedures as required by § 121.145(a)(1); and

(5) The written verification procedures as required by § 121.150(e).

 

§ 121.130 Identification of actionable process steps.

The owner, operator, or agent in charge of a facility must identify any actionable process steps, using the procedures described in either paragraph (a) or paragraph (b) of this section. The identification of actionable process steps and the assessment leading to that identification must be written.

(a) Key activity types. The owner, operator, or agent in charge of a facility must assess, for each type of food manufactured, processed, packed or held at the facility, whether the facility has one or more of the following key activity types and identify the actionable process steps associated with any key activity types present:

(1) Bulk liquid receiving and loading—a step in which a bulk liquid is received and unloaded from an inbound conveyance or loaded into an outbound conveyance where a contaminant can be intentionally introduced and, if it is, it is likely that the contaminant will be distributed throughout the liquid due to sloshing, movement, or turbulence caused by the receiving and unloading or loading activity.

(2) Liquid storage and handling—a step in which a liquid is contained in bulk storage tanks or in holding, surge, or metering tanks where a contaminant can be intentionally introduced and, if it is, it is likely that the contaminant will be distributed into the food.

(3) Secondary ingredient handling—a staging, preparation, addition, or rework step where a contaminant can be intentionally introduced into a relatively small amount of ingredient or rework and, if it is, it is likely that the contaminant will be distributed into a larger volume of food.

(4) Mixing and similar activities—a step, such as mixing, blending, homogenizing, or grinding where a contaminant can be intentionally introduced and, if it is, it is likely that the contaminant will be distributed into the food.

(b) Vulnerability assessment. The owner, operator, or agent in charge of a facility must conduct or have conducted, for each type of food manufactured, processed, packed or held at the facility, an evaluation to identify and prioritize the points, steps, and procedures in a food operation based on their vulnerability to intentional adulteration and to identify actionable process steps. Such vulnerability assessments must be performed by an individual(s) qualified by experience and/or training using appropriate methods.

 

§ 121.135 Focused mitigation strategies for actionable process steps.

(a) The owner, operator, or agent in charge of a facility must identify and implement focused mitigation strategies at each actionable process step to provide assurances that the significant vulnerability at each step will be significantly minimized or prevented and the food manufactured, processed, packed, or held by such facility will not be adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342).

(b) Focused mitigation strategies must be written.

(c) Focused mitigation strategies required under this section are subject to:

(1) Monitoring as required by § 121.140;

(2) Corrective actions as required by § 121.145; and

(3) Verification as required by § 121.150.

 

§ 121.140 Monitoring.

(a) The owner, operator, or agent in charge of a facility must establish and implement written procedures, including the frequency with which they are to be performed, for monitoring the focused mitigation strategies.

(b) The owner, operator, or agent in charge of a facility must monitor the focused mitigation strategies with sufficient frequency to provide assurances that they are consistently applied.

(c) All monitoring of focused mitigation strategies in accordance with this section must be documented in records that are subject to verification in accordance with § 121.150(a) and records review in accordance with § 121.150(c).

 

§ 121.145 Corrective actions.

(a) Corrective action procedures. (1) The owner, operator, or agent in charge of a facility must establish and implement written corrective action procedures that must be taken if focused mitigation strategies are not properly implemented.

(2) The corrective action procedures must describe the steps to be taken to ensure that appropriate action is taken to identify and correct a problem with implementation of a focused mitigation strategy to reduce the likelihood that the problem will recur.

(b) Documentation. All corrective actions taken in accordance with this section must be documented in records that are subject to verification in accordance with § 121.150(b) and records review in accordance with § 121.150(c).

 

§ 121.150 Verification.

(a) Monitoring. The owner, operator, or agent in charge of a facility must verify that monitoring is being conducted, as required by § 121.140.

(b) Corrective actions. The owner, operator, or agent in charge of a facility must verify that appropriate decisions about corrective actions are being made, as required by § 121.145.

(c) Implementation and effectiveness. The owner, operator, or agent in charge of a facility must verify that the focused mitigation strategies are consistently implemented and are effectively and significantly minimizing or preventing the significant vulnerabilities. As appropriate to the facility and the food, this must include review of the monitoring and corrective actions records within appropriate timeframes to ensure that the records are complete, the activities reflected in the records occurred in accordance with the food defense plan, the focused mitigation strategies are effective, and appropriate decisions were made about corrective actions.

(d) Reanalysis. The owner, operator, or agent in charge of a facility must:

(1) Conduct a reanalysis of the food defense plan:

(i) At least once every 3 years;

(ii) Whenever a significant change is made in the activities conducted at a facility operated by such owner, operator, or agent in charge if the change creates a reasonable potential for a new vulnerability or a significant increase in a previously identified vulnerability;

(iii) Whenever such owner, operator or agent in charge becomes aware of new information about potential vulnerabilities associated with the food operation or facility;

(iv) Whenever a focused mitigation strategy is found to be ineffective; and

(v) Whenever FDA requires reanalysis to respond to new vulnerabilities and developments in scientific understanding including, as appropriate, results from the Department of Homeland Security biological, chemical, radiological, or other terrorism risk assessment.

(2) Complete such reanalysis and implement any additional focused mitigation strategies needed to address the significant vulnerabilities identified, if any, before the change in activities at the facility is operative or, when necessary, during the first 6 weeks of production; and

(3) Revise the written plan if a significant change is made or document the basis for the conclusion that no additional or revised focused mitigation strategies are needed.

(e) Documentation. All verification activities taken in accordance with this section must be documented in records.

 

§ 121.160 Training.

(a) Personnel and supervisors assigned to actionable process steps must receive appropriate training in food defense awareness and their respective responsibilities in implementing focused mitigation strategies.

(b) All training received in accordance with this section must be documented in records.

 

§ 121.301 Records subject to the requirements of this subpart D.

(a) Except as provided by paragraph (b) of this section, all records required by subpart C of this part are subject to all requirements of this subpart D.

(b) The requirements of § 121.310 apply only to the written food defense plan.

 

§ 121.305 General requirements applying to records.

Records must:

(a) Be kept as original records, true copies (such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original records), or electronic records, which must be kept in accordance with part 11 of this chapter;

(b) Contain the actual values and observations obtained during monitoring;

(c) Be accurate, indelible, and legible;

(d) Be created concurrently with performance of the activity documented;

(e) Be as detailed as necessary to provide history of work performed; and

(f) Include:

(1) The name and location of the facility;

(2) The date and time of the activity documented;

(3) The signature or initials of the person performing the activity; and

(4) Where appropriate, the identity of the product and the production code, if any.

 

§ 121.310 Additional requirements applying to the food defense plan.

The food defense plan must be signed and dated by the owner, operator, or agent in charge of the facility:

(a) Upon initial completion; and

(b) Upon any modification.

 

§ 121.315 Requirements for record retention.

(a) All records required by this part must be retained at the facility for at least 2 years after the date they were prepared.

(b) The food defense plan must be retained for at least 2 years after its use is discontinued;

(c) Except for the food defense plan, offsite storage of records is permitted after 6 months following the date that the record was made if such records can be retrieved and provided onsite within 24 hours of request for official review. The food defense plan must remain onsite. Electronic records are considered to be onsite if they are accessible from an onsite location.

(d) If the facility is closed for a prolonged period, the records may be transferred to some other reasonably accessible location but must be returned to the facility within 24 hours for official review upon request.

 

§ 121.320 Requirements for official review.

All records required by this part must be made promptly available to a duly authorized representative of the Secretary of Health and Human Services upon oral or written request.

 

§ 121.325 Public disclosure.

Records required by this part will be protected from public disclosure to the extent allowable under part 20 of this chapter.

 

§ 121.401 Compliance.

(a) The operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is required to comply with, and is not in compliance with, section 418 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350g) or subparts C or D of this part is a prohibited act under section 301(uu) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(uu)).

(b) The failure to comply with section 420 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350i) or subparts C or D of this part is a prohibited act under section 301(ww) of the Federal Food, Drug, and Cosmetic Act.

Email David.Saxowsky@ndsu.edu

This material is intended for educational purposes only. It is not a substitute for competent legal counsel. Seek appropriate professional advice for answers to your specific questions.

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